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When does Stand-Alone Software qualify as a Medical Device in the European Union? - The CJEU’s Decision in SNITEM and what it implies for the next generation of Medical Devices.

Minssen, T., Mimler, M. and Mak, V., 2020. When does Stand-Alone Software qualify as a Medical Device in the European Union? - The CJEU’s Decision in SNITEM and what it implies for the next generation of Medical Devices. Medical Law Review. (In Press)

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DOI: 10.1093/medlaw/fwaa012

Abstract

This contribution analyses the first decision by the Court of Justice of the European Union (CJEU) on the qualification and regulation of stand-alone software as medical devices. Referring to the facts of the case and the applicable EU regulatory framework, the Court specifically found that prescription support software may constitute a medical device. This would even be the case where the software does not act directly in or on the human body. Yet, according to the CJEU it is necessary that the intended purpose falls within one or more of the 'medical purpose' categories of the regulatory definition of 'medical device'. The case has important implications, not only for specific legal debates. It also signifies a paradigm shift with a rapidly increasing digitalization of the health and life sciences. This highlights the demand for continuous debates over the necessary evolution of the regulatory framework applying to the interface of medical AI and Big Data.

Item Type:Article
ISSN:0967-0742
Uncontrolled Keywords:Software; Medical Devices Directive; medical devices; healthcare; eHealth
Group:Faculty of Media & Communication
ID Code:33981
Deposited By: Unnamed user with email symplectic@symplectic
Deposited On:07 May 2020 13:49
Last Modified:06 Jul 2020 10:54

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